Hyperphosphatemia

U.S. Food and Drug Administration Grants Full Approval for BALVERSA® to Treat Locally Advanced or Metastatic Bladder Cancer with Select Genetic Alterations

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星期五, 一月 19, 2024
Potassium, Death, Xerostomia, Patient, State, Overalls, Hyperphosphatemia, Shanda, OS, Bladder cancer, Stomatitis, PD-1, MUC, Survival, Fatigue, Sodium, Calcium, Cohort, Risk, FGFR, PD-L1, Xeroderma, Food, Constipation, Disease, Nail, Creatinine, Johnson & Johnson, Erdafitinib, Neoplasm, FDA, Confidence interval, Diarrhea, New Drug Application, FGFR3, Drug, Appetite, Pharmaceutical industry

RARITAN, N.J., Jan. 19, 2024 /PRNewswire/ -- Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for BALVERSA® (erdafitinib) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. BALVERSA® is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. This FDA action converts the April 2019 accelerated approval of BALVERSA® to a full approval based on the clinical and overall survival benefit observed in the Phase 3 THOR study. BALVERSA® is the first oral FGFR kinase inhibitor to be approved, and the first and only targeted treatment for patients with mUC and FGFR alterations.

Key Points: 
  • BALVERSA® is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy.
  • This FDA action converts the April 2019 accelerated approval of BALVERSA® to a full approval based on the clinical and overall survival benefit observed in the Phase 3 THOR study.
  • BALVERSA® is the first oral FGFR kinase inhibitor to be approved, and the first and only targeted treatment for patients with mUC and FGFR alterations.
  • This model is part of the Company's ongoing commitment to provide high-quality products, services, access, and support to healthcare professionals and patients.

Ardelyx Provides Update on Growing Commercial Momentum and 2024 Strategic Priorities

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星期一, 一月 8, 2024
Hyperphosphatemia, Food, Nephrology, Constipation, Risk, Death, Diarrhea, FDA, Master of Science, Incidence, Prescription, Bank statement, Rat, IBS-C, Calendar, Abdominal distension, Emeritus, Growth, Investment, Webcast, Patient, Human, Gastroenterology, Dehydration, Safety, Pharmaceutical industry

WALTHAM, Mass., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today provided an update on the company’s progress in 2023 and initial expectations for 2024.

Key Points: 
  • “2023 was a landmark year for Ardelyx, marking our first full year as a commercial entity and the approval and launch of our second first-in-class product.
  • XPHOZAH® joins IBSRELA in our portfolio of important treatment options for patients with unmet needs,” said Mike Raab, president and chief executive officer.
  • We are poised to continue with a growth trend in 2024.
  • Ardelyx currently expects full-year 2024 U.S. net product sales revenue for IBSRELA to be between $140.0 and $150.0 million.

Unicycive Therapeutics Announces Enrollment of First Patient in Pivotal Clinical Trial for Oxylanthanum Carbonate (OLC) in Patients with Chronic Kidney Disease on Dialysis

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星期一, 十二月 18, 2023
Hyperphosphatemia, Quality of life, Physician, OLC, TID, Kidney disease, Trial of the century, NDA, MD, Therapy, Pharmacokinetics, Chronic kidney disease, LOS, Patient, Safety, Dialysis, CKD, Pharmaceutical industry

LOS ALTOS, Calif., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today announced the enrollment of the first patient in its open-label, single-arm, multicenter, multidose pivotal clinical trial with Oxylanthanum Carbonate (OLC).

Key Points: 
  • LOS ALTOS, Calif., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today announced the enrollment of the first patient in its open-label, single-arm, multicenter, multidose pivotal clinical trial with Oxylanthanum Carbonate (OLC).
  • OLC is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.
  • “The initiation of patient enrollment in our OLC pivotal clinical trial is a critical milestone as we strive to reduce the pill burden and improve quality of life for individuals with chronic kidney disease on dialysis,” said, Shalabh Gupta, MD, Chief Executive Officer of Unicycive.
  • Once titrated to a clinically effective dose, participants will then be treated for four weeks to evaluate serum phosphate levels.

Jemincare Announces 6 Approvals of Clinical Trials for its Innovative Drugs

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星期二, 十二月 26, 2023
Hyperphosphatemia, Quality of life, Immunotherapy, Immune system, Klebsiella pneumoniae, FDA, PD-1, Renal cell carcinoma, Research, Bladder cancer, TKI, Cancer, Clinical trial, Pseudomonas aeruginosa, Acinetobacter baumannii, Chronic kidney disease, Phosphorus, Kidney disease, NMPA, BCG, Proteinuria, Escherichia coli, Kidney, Edema, National Medical Products Administration, Patient, Drug resistance, CKD, Dialysis, Gram-negative bacteria, Pharmaceutical industry

On December 20, NMPA has approved a clinical trial for JMKX003801 to treat serious infection caused by Gram-negative bacteria.

Key Points: 
  • On December 20, NMPA has approved a clinical trial for JMKX003801 to treat serious infection caused by Gram-negative bacteria.
  • Drug resistance of antibiotics, especially carbapenem resistance, in Escherichia coli, Klebsiella pneumoniae, Acinetobacter baumannii and Pseudomonas aeruginosa has risen year by year.
  • On December 12, NMPA has approved a clinical trial for JMKX003142 to treat renal edema.
  • On December 12, FDA has approved a clinical trial for JMKX000197 to treat BCG-unresponsive non-muscle-invasive bladder cancer, and earlier on October 19, NMPA has approved the clinical trial.

XPHOZAH® (tenapanor) Granted Orphan Drug Designation by U.S. FDA for the Treatment of Pediatric Hyperphosphatemia

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星期三, 十一月 15, 2023
Chronic kidney disease, Hyperphosphatemia, China Biologic Products, Orphan, Patient, Dialysis, Food, CKD, FDA, Pharmaceutical industry

WALTHAM, Mass., Nov. 15, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to XPHOZAH® (tenapanor) for the treatment of pediatric hyperphosphatemia.

Key Points: 
  • WALTHAM, Mass., Nov. 15, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to XPHOZAH® (tenapanor) for the treatment of pediatric hyperphosphatemia.
  • XPHOZAH is a single tablet taken twice daily that offers a first-in-class mechanism of action that blocks phosphate absorption through its primary pathway.
  • “We are pleased that the FDA has recognized the important need among pediatric patients with hyperphosphatemia for treatment options,” said Mike Raab, president and chief executive officer of Ardelyx.
  • In October, XPHOZAH was approved by the FDA to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.

Unicycive Announces Third Quarter 2023 Financial Results and Provides Business Update

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星期二, 十一月 14, 2023
NDA, Chronic kidney disease, Hyperphosphatemia, Chemistry, Food, Therapy, Type, IND, Kidney disease, Clinical trial, Administration, Insurance, Patient, LOS, Agency, Research, Dialysis, FDA, Pharmacokinetics, Nephrology, Trial of the century, R, CMC, Research and development, Doctor of Philosophy, American Journal, Society, Travel, Drug development, Pharmaceutical industry, Management, OLC

LOS ALTOS, Calif., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the “Company” or “Unicycive”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the third quarter ended September 30, 2023, and provided a business update.

Key Points: 
  • LOS ALTOS, Calif., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the “Company” or “Unicycive”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the third quarter ended September 30, 2023, and provided a business update.
  • We also remain very active within the the medical community with a booth at Kidney Week and positive results published on the phosphate binding capacity for OLC,” concluded Dr. Gupta.
  • Unicycive believes that results from this pivotal trial will enhance the OLC data package from preclinical studies and our previously disclosed bioequivalence study.
  • Dr. Kenkare-Mitra brings Unicycive expertise spanning research, preclinical and clinical development, translational medicine, manufacturing, and regulatory.

Ardelyx Announces XPHOZAH® (tenapanor) Now Available in the United States

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星期一, 十一月 6, 2023
Chronic kidney disease, CKD, Dialysis, Patient, Kidney, Hyperphosphatemia, Pharmacy, Pharmaceutical industry, Hospital

WALTHAM, Mass., Nov. 06, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced XPHOZAH is now available for shipment to partner pharmacies. XPHOZAH® (tenapanor) is indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. XPHOZAH is a single tablet taken twice daily that offers a first-in-class mechanism of action that blocks phosphate absorption through its primary pathway.

Key Points: 
  • WALTHAM, Mass., Nov. 06, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced XPHOZAH is now available for shipment to partner pharmacies.
  • XPHOZAH is a single tablet taken twice daily that offers a first-in-class mechanism of action that blocks phosphate absorption through its primary pathway.
  • Ardelyx will integrate XPHOZAH into its established patient services program, ArdelyxAssist™.
  • ArdelyxAssist is an innovative, digital-forward patient services program that provides access and affordability support for patients, with integration into medical office work processes and connectivity to patients and health care providers.

Ardelyx Shares Positive Data from Studies of XPHOZAH® (tenapanor), a First-in-Class Phosphate Absorption Inhibitor, at ASN Kidney Week 2023

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星期五, 十一月 3, 2023
Spotlight, Education, Incidence, Food, Diarrhea, Sevelamer, Doctor of Philosophy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, American Society of Nephrology, SAE, Chronic kidney disease, Quality of life, Dialysis, ASN, Kidney disease, Peritoneal dialysis, CKD, Safety, Kidney, Hospital, Pennsylvania Convention Center, Cohort, Memory, Pharmaceutical industry, Phosphorus, Patient, MD, Hyperphosphatemia, Nephrology

Ardelyx’s presence at Kidney Week 2023 will honor the memory of Derek Forfang, Chair of the Ardelyx Patient Advisory Council and a passionate advocate for patients with kidney disease.

Key Points: 
  • Ardelyx’s presence at Kidney Week 2023 will honor the memory of Derek Forfang, Chair of the Ardelyx Patient Advisory Council and a passionate advocate for patients with kidney disease.
  • XPHOZAH offers a different mechanism of action that blocks phosphate absorption at the primary pathway and is administered as a single tablet taken twice daily.
  • Additionally, Ardelyx is hosting an XPHOZAH Exhibitor Spotlight at ASN Kidney Week 2003.
  • Director of Home and Peritoneal Dialysis Programs, Boise Kidney & Hypertension Institute, and by David Spiegel, MD, Vice President of Nephrology at Ardelyx.

Ardelyx Reports Third Quarter 2023 Financial Results and Updates 2023 U.S. IBSRELA® Net Sales Revenue Guidance

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星期二, 十月 31, 2023
Rat, Research, Constipation, American College, Food, Northside Hospital, Prescription, Dehydration, Risk, New Drug Application, CKD, Human, Sale, MPH, Diarrhea, Jefferies Group, Journal, Chronic kidney disease, Irritable bowel syndrome, NDA, Safety, App, Investment, Patient, D, Fosun Pharma, IBS-C, Hyperphosphatemia, ACG, Growth, Clinical trial, SLR, Kyowa Kirin, FDA, Incidence, Conversation, Regulation of tobacco by the U.S. Food and Drug Administration, American College of Gastroenterology, Society, Death, Abdominal distension, Dialysis, Pharmaceutical industry, Fine chemical, Beauty salon, Video game, Nursing, Birth control, Health, Motility, RD

WALTHAM, Mass., Oct. 31, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today reported financial results for the third quarter ended September 30, 2023 and provided a business update.

Key Points: 
  • “Demonstrating consistent, quarter-over-quarter growth of IBSRELA prescriptions during the third quarter, we achieved a 22 percent increase in net sales revenue.
  • We have raised our full year U.S. net sales revenue guidance for IBSRELA, reflecting the important benefit this product is offering to patients.
  • Driven by increased demand for IBSRELA, the company reported net sales revenue of $22.3 million in the third quarter, 22 percent quarter-over-quarter growth compared to the second quarter of 2023.
  • Ardelyx currently expects full-year 2023 U.S. net product revenue for IBSRELA to be between $76.0 and $78.0 million.

FDA Approves XPHOZAH® (tenapanor), a First-in-Class Phosphate Absorption Inhibitor

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星期三, 十月 18, 2023
FDA, ET, Stanford University, Food, Hyperphosphatemia, Diarrhea, Physician, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Kidney, Maintenance, Phosphorus, Chronic kidney disease, Dialysis, Clinical trial, Medicine, CKD, Safety, Patient, Pharmaceutical industry

WALTHAM, Mass., Oct. 17, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has approved XPHOZAH® (tenapanor), the first and only phosphate absorption inhibitor, indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. XPHOZAH is a single tablet taken twice daily that offers a first-in-class mechanism of action that blocks phosphate absorption through its primary pathway.

Key Points: 
  • XPHOZAH is a single tablet taken twice daily that offers a first-in-class mechanism of action that blocks phosphate absorption through its primary pathway.
  • It is also a significant accomplishment for everyone at Ardelyx,” said Mike Raab, president and chief executive officer of Ardelyx.
  • XPHOZAH is a phosphate absorption inhibitor.
  • In patients not adequately responding to phosphate binder therapy, XPHOZAH has been shown to help increase the proportion of patients achieving target serum phosphate concentrations.